Forms and Templates

Institutional Review and Additional Requirements

Institutional approval must be obtained prior to any new Investigator-Sponsored Multi-Center Trial, or add-site submission to OHRS. The specific review requirements may vary by institution, but this requirement includes all:

Sponsor-Investigators will instead follow their home institution's process to obtain multi-center trial approval. Go to the Institutional Review Information tab on this page for more details.

In order to add non-DF/HCC sites to an Investigator-Sponsored trial, OHRS will need to receive a copy of the completed Institutional Approval Form for Multi-Center Trials, as provided by your institution.

Trials and external site that have a current approval from the DF/HCC Multi-Center Coordinating Committee (MCC) do not need to re-submit for institutional review. The MCC Approval form is valid, through it's expiration date (typically one year) to be submitted to OHRS for a new trial, or an add-site amendment.

The cut-off date for new submissions to the DF/HCC MCC was Thursday, August 24, 2017. The MCC will no longer accept submissions for new trials or add-sites.

For new submissions, please go to the "How to Obtain Multi-Center Approval" tab at the top of this page.

Per MULTI-100, "A DF/HCC Sponsor-Investigator planning to conduct a Multi-Center Trial for the first time will be required to complete appropriate training as designated by the Office of Data Quality (ODQ) prior to the initiation of research at an External Site."

Sponsor-Investigators who are planning to conduct multi-center research for the first time are encouraged to complete this training at any time.

Sponsor-Investigators who are required to complete the training may also be identified at the time of institutional or departmental review and contacted by ODQ to fulfill the requirement.

A DF/HCC Sponsor-Investigator planning to conduct a DF/HCC Multi-Center Trial for the first time will be required to complete the New Multi-Center Sponsor training as provided by the Office of Data Quality (ODQ) prior to the initiation of research at any external site.

This requirement may be waived at the discretion of the ODQ Director for trials that are deemed minimal risk by the IRB.